Ferric Carboxymaltose

Registered South African indications:

• Iron deficiency

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Known serious hypersensitivity to other parenteral iron products
• Anaemia not attributed to iron deficiency
• Evidence of iron overload or disturbances in the utilisation of iron

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• History of severe asthma, eczema or other atopic allergy
• Immune or inflammatory conditions
• Acute or chronic infection
• Sodium controlled diet

Forms avail. in SA and covered in this monograph: inj

Iron deficiency
- When oral iron preparations are ineffective or cannot be used

• IV: Cumulative dose is calculated for each patient individually (see table below); Max: 1000mg/week

See additional prescribing points

A single administration should not exceed 15mg/kg (administration by injection) or 20mg/kg (administration by infusion)

Haemoglobin levels should be reassessed no earlier than 4 weeks post the final administration

Not established for use in children below 18 years

Pregnancy

• Caution
• There are limited data from the use of ferric carboxymaltose in pregnant women. A careful benefit/risk evaluation is required before use during pregnancy and ferric carboxymaltose should not be used during pregnancy unless clearly necessary
• Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with ferric carboxymaltose should be confined to the second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus
• Animal data suggest that iron released from ferric carboxymaltose can cross the placental barrier and that its use during pregnancy may influence skeletal development in the foetus

Breastfeeding

• Caution
• Clinical studies showed that transfer of iron from ferric carboxymaltose to human milk was negligible (≤1%). Based on limited data on breastfeeding women it is unlikely that ferric carboxymaltose represents a risk to the breastfed child

Renal Impairment

• Caution; no dose adjustment recommended  
  No safety data on haemodialysis-dependent chronic kidney disease patients receiving single doses of more than 200 mg iron are available

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Paraesthesia
• Dysgeusia
• Loss of consciousness
• Anxiety
• Malaise

Cardiovascular Disorders

• Tachycardia
• Flushing
• Hypertension
• Hypotension
• Phlebitis
• Syncope
• Presyncope
• Chest pain
• Peripheral oedema

Respiratory Disorders

• Dyspnoea
• Bronchospasm

Gastrointestinal Disorders

• Nausea and vomiting
• Dyspepsia
• Abdominal pain
• Constipation
• Diarrhoea
• Flatulence

Hepatobiliary Disorders

• Increased hepatic enzymes

Endocrine and Metabolic Disorders

• Hypophosphataemia
• Increased serum lactate dehydrogenase

Musculoskeletal Disorders

• Myalgia
• Back pain
• Arthralgia
• Pain in extremity
• Muscle spasms

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Urticaria
• Erythema
• Rash
• Angioedema
• Pallor
• Facial oedema
• Infusion site reactions

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylactoid reactions
• Fever

Oral iron therapy

• Full blood count
• Serum ferritin
• Iron saturation
• Vital signs

Dose calculation

The cumulative dose required for haemoglobin restoration and repletion of iron stores is calculated by the following Ganzoni formula:

Cumulative iron deficit [mg] = body weight [kg] x (target Hb - actual Hb) [g/dl] x 2,4 + iron storage depot [mg]

• Target Hb <35 kg = 13 g/dl (8,1 mmol/l)
• Target Hb >35 kg = 15 g/dl (9,3 mmol/l)

To convert Hb [mM] to Hb [g/dl]: multiply Hb [mM] by the factor 1,61145

• Factor 2,4 = 0,0034 (iron content of haemoglobin is 0.34%) x 0,07 (blood volume is 7% of body weight) x 10000 (conversion factor: 1g/dl = 10000 mg/l)
• Depot iron <35 kg = 15 mg/kg
• Depot iron 35 kg and above = 500 mg
• For patients <66kg the calculated cumulative dose is rounded down to the nearest 100 mg
• For patients >66 kg the calculated cumulative dose is rounded up to the nearest 100 mg

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, which is a carbohydrate polymer that releases iron. This iron is incorporated into haemoglobin, myoglobin, and iron-containing enzymes that are necessary for oxidative processes in living tissues.

Injection (per ml) 50mg

• Ferinject (Takeda) originator